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海特生物(300683):CPTⅢ期临床结果优异 继续关注后续进展

Haitian organism (300683): excellent clinical results in phase Ⅲ of CPT continue to follow-up progress.

萬聯證券 ·  Jun 17, 2020 00:00  · Researches

Events:

Recently, the company announced that: a clinical study of recombinant mutant human tumor necrosis factor-related apoptosis-inducing ligand (hereinafter referred to as "CPT") independently developed by Haite Biological shareholding Company Beijing Shadong Biotechnology Co., Ltd.-- comparison of CPT or placebo combined with thalidomide and dexamethasone in the treatment of patients with recurrent or refractory multiple myeloma multicenter, randomized, double-blind, Controlled phase Ⅲ clinical trial (CPT-MM301 project) The preliminary results were released on February 27, 2020. At present, the statistical analysis report of the CPT-MM301 project has been completed, and the main research results have been announced.

Main points of investment:

The preliminary clinical results of phase III are excellent, expanding the clinical advantages of phase II. In a phase II clinical trial of CPT completed in the past, CPT+TD showed certain advantages in terms of clinical efficacy and safety compared with the TD group alone. In the clinical results of this phase Ⅲ, CPT+TD treatment showed more significant efficacy, while continuing to maintain good safety and tolerance. As the first pro-apoptotic agonist to target death receptor 4 and death receptor 5 in TRAIL after completing the phase III clinical trial, the good experimental results bring optimistic news to the follow-up review and approval and commercial promotion. But similarly, CPT treatment will continue to face corresponding challenges in the follow-up clinical promotion, but we remain cautiously optimistic about it.

Profit forecast and investment advice: the company is expected to achieve a return net profit of 94 million, 115 million and 153 million respectively in 2020, 2021 and 2022; the corresponding EPS is 0.90,1.11,1.48 respectively; and the corresponding current stock price PE is 65 times, 53 times and 40 times respectively. The company is gradually getting rid of the business dependence of a single product, and with the diversification of business layout and the excellent clinical results of innovative drugs, the company is expected to usher in a new round of economic development cycle under the conditions of smooth progress of review and approval and commercialization in the future. Continue to recommend and maintain "increasing holdings"

Rating.

Risk factors: the risk of slow progress in the follow-up review of innovative drug projects and the risk that commercial performance is not as expected.

The translation is provided by third-party software.


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